ML031630964
| ML031630964 | |
| Person / Time | |
|---|---|
| Site: | Harris, Brunswick, Crystal River, Robinson  |
| Issue date: | 06/06/2003 |
| From: | Holt J Progress Energy Carolinas |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| PE&RAS-03-065 | |
| Download: ML031630964 (5) | |
Text
P e 10 CFR 26, Appendix A, Subpart B, 2.8(e)(4) bLProgress Energy PO Box 1551 411 Fayetteville Street AMall Raleigh NC 27602 Serial: PE&RAS-03-065 June 6, 2003 United States Nuclear Regulatory Commission ATTENTION: Document Control Desk Washington, DC 20555 BRUNSWICK STEAM ELECTRIC PLANT, UNIT NOS. 1 AND 2 DOCKET NOS. 50-325 AND 50-324/LICENSE NOS. DPR-71 AND DPR-62 SHEARON HARRIS NUCLEAR POWER PLANT, UNIT NO. 1 DOCKET NO. 50-400ALICENSE NO. NPF-63 H. B. ROBINSON STEAM ELECTRIC PLANT, UNIT NO. 2 DOCKET NO. 50-261/LICENSE NO. DPR-23 CRYSTAL RIVER UNIT 3 NUCLEAR GENERATING PLANT DOCKET NO. 50-302 / LICENSE NO. DPR-72 10 CFR 26 UNSATISFACTORY FITNESS-FOR-DUTY BLIND PERFORMANCE TESTING RESULTS Ladies and Gentlemen:
On April 29, 2003, Progress Energy Carolinas, Inc. EC)(also known as Carolina Power & Light Comn any) and Progress Energy Florida, Inc. (PEF) (also known as Florida Power Corporation) no;ified via telephone the NRC of the occurrence of an administrative error on a blind performance test specimen, pursuant to 10 CFR 26, Appendix A, Subpart B, Section 2.8 (eX5).
The PEC and PEF investigation of the incident was concluded on June 2? 2003. The Director, Forensic Toxicology, has reviewed the investigative findings and corrective actions, as documented in a signed letter dated June 5, 2003. The Director, Forensic Toxicology, is the person responsible for the day-to-day management and operation of the Department of Health and Human Service (HHS) certified laboratory.
Based on discussion with the NRC, the attached report on the investigation and the letter signed by the laboratory's Director, Forensic Toxicology, are being submitted pursuant to 10 CFR 26, Appendix A, Subpart B, Section 2.8 (e)(4).
This document contains no new regulatory commitment.
Please contact me at (919) 546-6901 if you need additional information.
Sicrely, es W. Holt Manager - Performance Evaluation & Regulatory Affairs HAS Attachments
United States Nuclear Regulatory Commission PE&RAS-03-065 Page 2 c: L. A. Reyes, USNRC Regional Administrator - Region II USNRC Resident Inspector - BSEP, Unit Nos. 1 and 2 USNRC Senior Resident Inspector - CR3 USNRC Senior Resident Inspector - SHNPP, Unit No. 1 USNRC Senior Resident Inspector - HBRSEP, Unit No. 2 G. West, USNRC NSIR/DNS/LPSS-OWFN, A 4 D8 B. L. Mozafari, NRR Project Manager - BSEP, Unit Nos. I and 2; CR3 C. P. Patel, NRR Project Manager - SHNPP, Unit No. 1; HBRSEP, Unit No. 2 J. A. Sanford - North Carolina Utilities Commission
United States Nuclear Regulatory Commission PE&RAS-03-065 Page 3 ATTACHMENT 1 Investigation Report Attachment 3 Sheet 1 of 1 Adverse Condition Investigation Form Form CAP-NGGC-0200-3-7 Action Request Number: 91108
- 1. Event Description
- CONFIRMATION LAB REPORTED RESULTS FOR TWO BLIND SPECIMENS INCONSISTENT WITH THE PRIMARY LAB. MRO CONTACTED AND REQUESTED BOTH THE PRIMARY AND SECONDARY LAB TO RE-ANALYZE THE SPECIMENS.
- 2. Problem Description / Investigation Summary:
Consider elements such as the following, as applicable:
- What Should Be: the requirement, standard, norm, or expectation:
Code of Regulations 10 part 26, Appendix A, 2.8 (e) requires licensee blind performance test procedures to be conducted at a quarterly rate of 10% of all samples submitted to the lab with an 80:20 negative/positive ratio as a quality assurance control. Progress Energy purchases control specimens from an HHS certified lab and submits them to Laboratory Corporation of America (LabCorp). LabCorp's specimen results are compared with the known blind sample.
A minimum of 10% of the blind samples submitted to the primary laboratory are forwarded to Progress Energy's secondary laboratory, Quest Diagnostics, for testing.
- What Is: the existing, as-found condition:
Quest Diagnostics reported two blind specimens with results inconsistent with the blind supplier and the primary lab.
Specimen Number El Sohlv Lab Corp Report Ouest Report 0157561663 Morphine 452 nglml Morphine 440 ng/ml Negative Codeine 438 ng/ml Codeine 408 ng/ml 0157561762 Negative Negative Morphine 431 ngld Codeine 402 ng/nd Progress Energy's Medical Review Officer was notified immediately and requested both the primary and secondary lab to reanalyze the samples. LabCorp's reanalysis confirmed their initial results. Upon reanalysis, Quest Diagnostics reported results consistent with the blind supplier and the primary lab.
Quest Diagnostics performed an internal investigation and determined that an administrative error by the certifying scientist had occurred at the result entry stage of the certification process, resulting in incorrect results being reported.
Additionally, the certifying scientist responsible for the error did not follow the laboratory's standard operating procedure for handling re-test specimens.
On 4/29/03 Lori Hayes, Sr. Regulatory Analyst, Nuclear Security, notified the NRC via telephone.
Time Line of Events 4/11/03 Blind specimen 0157561663 submitted to Lab Corp.
4/12103 Lab Corp received specimen 0157561663.
4/15/03 Blind specimen 0157561762 submitted to Lab Corp.
4/16/03 Lab Corp received specimen 0157561762.
Lab Corp reported negative results for specimen number 0157561762.
4/17/03 Lab Corp reported positive opiate results for specimen 0157561663.
4/17/03 Progress Energy's Medical Review Officer requested Lab Corp to send Bottle B of specimens 0157561663 and 0157561762 to Quest Diagnostics for split sample testing.
United States Nuclear Regulatory Commission PE&RAS-03-065 Page 4 AYfACHMENT 1 Investigation Report 4/20/03 Quest Diagnostics received specimen numbers 0157561663 and 0157561762.
4/21/03 Quest Diagnostics reported at 2247 hours0.026 days <br />0.624 hours <br />0.00372 weeks <br />8.549835e-4 months <br /> specimen 0157561663 as failed to reconfirm.
Quest Diagnostics reported at 2247 hours0.026 days <br />0.624 hours <br />0.00372 weeks <br />8.549835e-4 months <br /> specimen 0157561762 as positive for opiates.
4/22/03 Quest Diagnostic's reports for specimen numbers 0157561663, and 0157561762 reviewed and the reporting discrepancy identified. AR initiated.
Medical Review Officer notified.
Lab Corp and Quest Diagnostics requested to reanalyze specimens 0157561663 and 0157561762.
4/24/03 Quest Diagnostics reported re-analysis of specimen 0157561663 as positive for opiates.
Quest Diagnostics reported re-analysis of specimen 0157561762 as negative.
4/28/03 Quest Diagnostic's investigative response submitted to Progress Energy.
4/29/03 Lori Hayes notified NRC via telephone.
5/01/03 Lab Corp reported re-analysis of specimen 0157561762 as negative.
5/03/03 Lab Corp reported re-analysis of specimen 0157561663 as positive for opiates.
- 3. Inappropriate Acts / Equipment Failures
- For each Inappropriate Act(s) identify the Work Group involved
- 4. Apparent Causal Factor associated with each Inappropriate Act / Equipment Failure
- Q2 External Entities, Vendor/Supplier
- 5. Corrective Action Plan Apparent Planned / Completed Action Assignment Assignee / Initial Causal Type Concurred By Due Date Factor# (Annotate Committed Assignments as Comitted)
I Reanalysis of specimens by the Lab Corp CORR Lab Corp Complete 2 Reanalysis of specimens by Quest Diagnostics CORR Quest Complete 3 Retrain certifying scientist on applicable protocols CORR Quest Complete and procedures to include secondary review of ten analytical batches of data by a senior lab representative 4 Capture event in the next NRC Six Month Summary Cindy 8/30/03 Report Cunningham
United States Nuclear Regulatory Commission PE&RAS-03-065 Page 5 ATTACHMENT 2 Director, Forensic Toxicology, Letter Qa t L~pn
'417 rrn . nv luro 5, 2003 Cindy Cunningha Carolina Power & Ligbt Co-412 S Winito Street Re1igh, NC 27601 Dear Ms. CWmina-It is the policy oriQuest Diagosircs Incoporated to conduct a though investigation and to provide an accmrate response to each clicats request ima timcly - maer. Punsuant to your reques andi s hc individual resonsoble for the day-to-day management and operation of this MiS-certffied laotory, I have reviewed the iwesiWAivc fidings and corrective actionse taken by the labomtory, as doemented in Progrss Energy's invstigation for iA 91108. In particular, the event was cmu by an administ-ative error by the tfying cientit during the result entry sta, resulting i incouxt results being reported. The ce4iifyhg scicn6st responsible for the error did not follow the Laiborary's standaxd operat procedure for handling rc-test specims. As orrecve actions, the indvidual was rctz-aincd on al applicable protocols and procedures to include secondary reiw of ten anaytical batches of data by a senior lab representaive. tese corrective actions have been completed If you have any questons regarding the contents of this lter, please contact me dircctly at (800) 729-6432 x6107.
Rcspetully, ElW AZary Director of Forensic Toxicology